Classes
DEA Class; Rx
Common Brand Names; Viberzi
- IBS Agents
Description
Oral mu and kappa opioid receptor agonist and delta opioid receptor antagonist
Indicated for use in adults to treat irritable bowel syndrome with diarrhea (IBS-D)
Stop treatment if severe constipation lasting more than 4 days develops
Indications
Indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D).
Indicated for diarrhea-predominant irritable bowel syndrome (IBS-D) in adult men and women
Contraindications
Documented hypersensitivity to drug or components of the formulation
Patients who do not have a gallbladder
Known or suspected gallbladder obstruction, biliary duct obstruction or sphincter of Oddi disease or dysfunction; increased risk for sphincter of Oddi spasm
Alcoholism, alcohol abuse, alcohol addiction, or in patients who drink >3 alcoholic beverages/day; increased risk of pancreatitis
History of pancreatitis, pancreatic duct obstruction, or structural diseases of the pancreas; increased risk of acute pancreatitis
Severe hepatic impairment (Child-Pugh C); risk of significantly increased eluxadoline plasma concentrations
History of chronic or severe constipation or sequelae from constipation, or known mechanical GI obstruction; increased risk of bowel obstruction
Adverse Effects
- Constipation (7-8%)
- Nausea (7-8%)
- Abdominal pain (6-7%)
- URT infection (3-5%)
- Vomiting (4%)
- Nasopharyngitis (3-4%)
- Abdominal distention (3%)
- Bronchitis (3%)
- Dizziness (3%)
- Flatulence (3%)
- Rash (3%)
- Increased ALT (2-3%)
- Fatigue (2-3%)
- Viral gastroenteritis (1-3%)
Warnings
Eluxadoline is a mu opioid receptor agonist; because of this mechanism of action, the potential for increased risk of sphincter of Oddi spasm exists, resulting in pancreatitis or hepatic enzyme elevation associated with acute abdominal pain (see Contraindications)
There is risk of sphincter of Oddi spasm, resulting in pancreatitis or hepatic enzyme elevation associated with acute abdominal pain (e.g., biliary-type pain) in patients receiving therapy; instruct patients to immediately stop therapy and seek medical attention if they experience symptoms suggestive of sphincter of Oddi spasm such as acute worsening of abdominal pain
Increased risk of pancreatitis not associated with sphincter of Oddi spasm reported; most cases were associated with excessive alcohol use
In patients with a gallbladder, evaluate a patient’s alcohol intake prior to starting therapy; instruct patients to avoid chronic or acute excessive alcohol use while in therapy; monitor for new or worsening abdominal pain that may radiate to back or shoulder, with or without nausea and vomiting; instruct patients to immediately stop therapy and seek medical attention if they experience symptoms suggestive of pancreatitis such as acute abdominal or epigastric pain radiating to back or shoulder associated with elevations of pancreatic enzymes with or without nausea and vomiting
Constipation requiring hospitalization reported; severe cases with development of intestinal obstruction, intestinal perforation, and fecal impaction, requiring intervention, also reported; instruct patients to stop therapy and immediately contact their healthcare provider if they experience severe constipation; avoid use with other drugs that may cause constipation
Pregnancy and Lactation
No studies in pregnant women
Unknown if distributed in human breast milk
Maximum Dosage
200 mg/day PO.
200 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Eluxadoline
tablet: Schedule IV
- 75mg
- 100mg
